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User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation

17 May 2017

Medical Device Alert
Last week, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) advanced the Food and Drug Administration (FDA) Reauthorization Act of 2017 (S. 934), by a vote of 21–2.

The bill seeks to reauthorize user fees for medical products (including medical devices) for another five years through 30 September 2022. Its passage considered inevitable, the reauthorization package proposes to extend the device user fee framework to include a new fee for de novo reclassification requests equal to 30 percent of the fee for a premarket application. In addition, several individual bills related to the regulation of medical devices are incorporated in this draft legislation.

Read the full client alert "User Fee Reauthorization Bill Includes Legislation Proposed to Improve Medical Device Regulation." 

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